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Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your serious quality problems.
CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems. This webinar will help you improve your root cause analysis leading to real and lasting improvements.
- FDA Expectations
- A Methodical Process for Root Cause Analysis
- Root Cause Analysis Techniques
- Do's and Don'ts
- Myths of Root Cause Analysis
- Documentation Expectations
- Build the right team
- Develop a problem statement
- Data collection
- Analysis tools and techniques
- How to verify your results
- RCA tool box
- Real lessons learned
- Dos and don’ts of RCA
- Case studies
- Quality, Manufacturing, Design, or Process Engineers
- Compliance Specialists, Auditors
- Compliance Managers
- CAPA Specialists / Managers
- Regulatory Affairs Managers
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.